Chronic Stable AnginaPhase 2NCT01239511
Phase IIb Study of STA-2 in Patients With Chronic Stable Angina
A Phase 2 study testing green tea polyphenols (STA-2) in people with Chronic Stable Angina, run by Sinphar Pharmaceutical Co., Ltd at 5 sites in Taiwan.
Trial summary
The objective of this study is to evaluate the dose-response of three different dose levels of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in patients with chronic stable angina. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Stable Angina
- What is being tested?
- green tea polyphenols (STA-2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 5 sitesTaiwan
- Study dates
- Nov 2010to Apr 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≧ 20 years;
- Subjects weight > 50 kg
- subjects who had more than 50% coronary stenosis documented by catheterization or ever received coronary intervention;
- The two ETT results at screening (Visit 1) and baseline (Visit 2) show greater than or equal to 1 mm ST-segment depression within exercise duration;
- The difference in exercise duration between screening (Visit 1) and baseline (Visit 2) do not exceed 20% of the longer test;
- Able to provide written informed consent.
Who cannot join
- Subjects with pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;
- Subjects with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, subjects who need digoxin or digitalis;
- Subjects with any resting EKG abnormalities preventing the interpretation of ischemia as judged by the investigator;
- Subjects with COPD requiring bronchodilators;
- Subjects with impaired hepatic function (defined as AST or ALT > 2X the upper limit of normal values), or impaired renal function (defined as serum creatinine > 1.5 mg/dL), or diagnosis of any chronic renal/hepatic disease;
- Subjects with documented evidence of gastroduodenal ulcer disease, gastrointestinal bleeding or other gastrointestinal disease within the preceding 3 months as judged by investigator;
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- Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with safety assessments during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, or hematological disease as determined by the clinical judgment of the investigator;
- Subject with any conditions that could interfere the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stoke);
- Female subjects of childbearing potential who:
- are lactating;
- have positive pregnancy test (urine) at V1;
- Subject has received any investigational agent within 28 days prior to the first dose of investigational product;
- Subjects who have had administered STA-2 in prior clinical trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan
Chi Mei Medical Center
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University-Shuang Ho Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Dose-Response and Safety of STA-2 in Patients With Chronic Stable Angina
The objective of this study is to evaluate the dose-response of three different dose levels of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in patients with chronic stable angina.
Read the detailed description
The objective of this study is to evaluate the dose-response of three different dose levels of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in patients with chronic stable angina.
Treatment Group A:
150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
Treatment Group B:
300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
Treatment Group C:
450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
Placebo Group:
Placebo capsule, 2 capsules t.i.d., after meal
- Conditions
- Chronic Stable Angina
- Being tested
- green tea polyphenols (STA-2)
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
green tea polyphenols (STA-2)Drug
2 capsules t.i.d., after meal
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | placebo capsule 2# t.i.d./day Receives: Drug: green tea polyphenols (STA-2) |
| Treatment Group A | Experimental | 150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day) Receives: Drug: green tea polyphenols (STA-2) |
| Treatment Group B | Experimental | 300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day) Receives: Drug: green tea polyphenols (STA-2) |
| Treatment Group C | Experimental | 450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day) Receives: Drug: green tea polyphenols (STA-2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Exercise Time (Seconds)
the time difference of total exercise time from V2 to V5 compare to placebo
Measured: 6 weeks after the first exercise tolerance testing is conducted
Secondary outcomes (8)
Change in Time to Onset of Angina From Baseline to the Final Visit
Measured: 6 weeks
Changes in Time to 1mm ST-segment Depression During ETT From Baseline to Final Visit
Measured: 6 weeks
Changes in Time to Maximum ST-segment Depression During ETT From Baseline to the Final Visit
Measured: 6 weeks
Changes in Angina Frequency in Subject's Diary From Baseline to All Visits
Measured: 6 weeks
Change in Consumption of Short-acting Nitrates From Baseline to All Visits
Measured: 6 weeks
Change in Pharmacological Parameters (Oxidized-LDL), Isoprostane and High-sensitivity Hs-CRP From Baseline to All Visits
Measured: 6 weeks
Change in Lipid Profiles (HDL-C, LDL-C, Total Cholesterol, Triglyceride) From Baseline to All Visits
Measured: 6 weeks
Dose-response Relationship of Three Different Dose Levels of STA-2 Versus Placebo Control in Change in Total Exercise Time.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinphar Pharmaceutical Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chuen-Den Tseng, MD, Ph.D, Principal investigator, Department of Cardiology National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239511
- Sponsor's protocol ID
- MCCD09004A
- Status last verified
- Aug 2014
- First submitted
- 10 Nov 2010
- Last updated
- 27 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Dose-Response and Safety of STA-2 in Patients With Chronic Stable Angina
- ClinicalTrials.gov ID
- NCT01239511
- Acronym / sponsor ID
- MCCD09004A
- Conditions
- Chronic Stable Angina
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Sinphar Pharmaceutical Co., LtdUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Posted 27 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the dose-response of three different dose levels of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in patients with chronic stable angina.
Detailed description
The objective of this study is to evaluate the dose-response of three different dose levels of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in patients with chronic stable angina.
Treatment Group A:
150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
Treatment Group B:
300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
Treatment Group C:
450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
Placebo Group:
Placebo capsule, 2 capsules t.i.d., after meal
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: green tea polyphenols (STA-2)placebo capsule 2# t.i.d./day |
| Treatment Group A | Experimental | Drug: green tea polyphenols (STA-2)150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day) |
| Treatment Group B | Experimental | Drug: green tea polyphenols (STA-2)300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day) |
| Treatment Group C | Experimental | Drug: green tea polyphenols (STA-2)450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged ≧ 20 years;
- Subjects weight > 50 kg
- subjects who had more than 50% coronary stenosis documented by catheterization or ever received coronary intervention;
- The two ETT results at screening (Visit 1) and baseline (Visit 2) show greater than or equal to 1 mm ST-segment depression within exercise duration;
- The difference in exercise duration between screening (Visit 1) and baseline (Visit 2) do not exceed 20% of the longer test;
Key exclusion criteria (13 listed)
- Subjects with pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;
- Subjects with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, subjects who need digoxin or digitalis;
- Subjects with any resting EKG abnormalities preventing the interpretation of ischemia as judged by the investigator;
- Subjects with COPD requiring bronchodilators;
- Subjects with impaired hepatic function (defined as AST or ALT > 2X the upper limit of normal values), or impaired renal function (defined as serum creatinine > 1.5 mg/dL), or diagnosis of any chronic renal/hepatic disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| green tea polyphenols (STA-2)2 capsules t.i.d., after meal | Drug | Placebo group, Treatment Group A, Treatment Group B, Treatment Group C |
Primary outcome
Change in Total Exercise Time (Seconds)
Time frame: 6 weeks after the first exercise tolerance testing is conducted
the time difference of total exercise time from V2 to V5 compare to placebo
8 secondary outcomes
Change in Time to Onset of Angina From Baseline to the Final Visit
Time frame: 6 weeks
Changes in Time to 1mm ST-segment Depression During ETT From Baseline to Final Visit
Time frame: 6 weeks
Changes in Time to Maximum ST-segment Depression During ETT From Baseline to the Final Visit
Time frame: 6 weeks
Changes in Angina Frequency in Subject's Diary From Baseline to All Visits
Time frame: 6 weeks
Change in Consumption of Short-acting Nitrates From Baseline to All Visits
Time frame: 6 weeks
Change in Pharmacological Parameters (Oxidized-LDL), Isoprostane and High-sensitivity Hs-CRP From Baseline to All Visits
Time frame: 6 weeks
Change in Lipid Profiles (HDL-C, LDL-C, Total Cholesterol, Triglyceride) From Baseline to All Visits
Time frame: 6 weeks
Dose-response Relationship of Three Different Dose Levels of STA-2 Versus Placebo Control in Change in Total Exercise Time.
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuen-Den Tseng, MD, Ph.D principal investigator
Department of Cardiology National Taiwan University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing green tea polyphenols (STA-2) in people with Chronic Stable Angina, run by Sinphar Pharmaceutical Co., Ltd at 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Exercise Time (Seconds) (time frame: 6 weeks after the first exercise tolerance testing is conducted). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2014.